Pelvic Floor Dysfunction, Sexual Dysfunction Female, Vibrator
Conditions
Brief summary
Limited data exist describing the use and role of vibrators in a urogynecology population and no randomized controlled trials investigating the use of vibrators as a therapeutic tool to enhance sexual and pelvic floor function in urogynecology patients has been conducted. This study aims to evaluate the efficacy of vibrator use in improving sexual and pelvic floor function in urogynecology patients who report sexual dysfunction.
Interventions
OTHERInstructional handout
A handout on how to improve sexual dysfunction/function will be provided
DEVICEVibrator
An FDA approved vibrator device to improve sexual function will be provided
Sponsors
Albany Medical College
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* • Women aged 18 and over presenting to the urogynecology clinic. * Women diagnosed with one of the following urogynecologic conditions o Pelvic organ prolapse, urgency incontinence, overactive bladder, stress urinary incontinence, fecal incontinence, recovering from a urogynecologic surgery over 6 weeks following surgery and clear for intercourse. Patients post op who continue to have pelvic floor dysfunction can be candidates for the study if they continue to have one of the pelvic floor dysfunctions listed. * Patient will be screened with the FSFI and will be eligible if they score less than 26.55 * Patient's must be willing to use a vibrator. * Able to provide informed consent. * Not currently using a vibrator or has not used a vibrator in the past 3 months. * Able to read and write in English
Exclusion criteria
* • Patients with cognitive impairment. * Patients with refusal or discomfort with vibrator use. * Currently using a vibrator or has used a vibrator in the past 3 months. * Patients unable to provide informed consent. * Patients not clear for intercourse following their surgery * Patients with surgery within 2 months of recruitment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Female Sexual Function Index | up to 12 weeks | A 19 question validated survey on sexual function with lower scores indicating worse outcome |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| sexual satisfaction index | up to 12 weeks | a validated questionnaire on sexual satisfaction with lower scores indicating worse outcomes |
| female genitourinary pain index | up to 12 weeks | validated survey on genitourinary pain in females with lower scores indicating worse outcomes |
| patient health questionnaire 9 | up to 12 weeks | validated questionnaire on depression with lower scores indicating worse outcomes |
| Pelvic Floor Distress Inventory -20 | up to 12 weeks | 20 question validated survey on pelvic floor dysfunction with lower scores indicating worse outcomes |
| Pelvic Organ Prolapse incontinence sexual questionnaire 12 | up to 12 weeks | a 12 question validated survey on sexual function in patients with pelvic floor dysfunction with lower scores indicating worse outcomes |
Countries
United States
Contacts
Primary ContactBrittany Roberts, MD
Backup ContactErin Deverdis, MD
Outcome results
None listed